BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    SERODOT CMV (CYTOMEGALOVIRUS) IGG TEST KIT

    K Number: K875361 · Decision May 13, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    29
    Registration Numbers
    29
    Same Product Code
    57
    Applicant Total
    20
    Review Days
    134

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    SERODOT CMV (CYTOMEGALOVIRUS) IGG TEST KIT
    K Number
    K875361
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3175
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Disease Detection International, Inc.
    Date Received
    December 31, 1987
    Decision Date
    May 13, 1988
    Product Code
    LFZ
    Advisory Committee
    Microbiology
    Review Advisory Committee
    MI
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LFZ Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (LFZ), ordered by most recent decision date.

    Architect CMV IgG

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Elecsys CMV IgG

    FDA 510(k)
    FDA Class 2 ·Microbiology

    ADVIA Centaur CMV IgG and ADVIA Centaur CMV IgG Quality Control

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Elecsys CMV IgM

    FDA 510(k)
    FDA Class 2 ·Microbiology

    LIAISON® CMV IgG and LIAISON® CMV IgG Serum Control Set

    FDA 510(k)
    FDA Class 2 ·Microbiology

    ELECYS CMV IGM IMMUNOASSAY; ELECYS PRECICONTROL CMV IGM

    FDA 510(k)
    FDA Class 2 ·Microbiology
    View all

    Other Clearances by Disease Detection International, Inc.

    K Number Device Name
    K943252 PRO-STEP LH OVULATION PREDICTION TEST
    K925303 PRO-STEP PT HCG
    K925125 PRO-STEP HCG
    K911826 IMMUNOCARD HCG ONE STEP (I-S) TEST KIT
    K902571 MODIFICATION OF SEROCARD RUBELLA IGG TEST
    K903070 SEROCARD HSV IGG ANTIBODY TEST KIT
    K895912 IMMUNOCARD HCG II-S TEST KIT
    K896109 IMMUNOCARD STREP A TEST
    K884247 MODIFIED DDI SEROCARD RUBELLA IGG TEST KIT
    K884248 MODIFIED DDI SEROCARD CMV IGG TEST KIT
    Search all 20 clearances from Disease Detection International, Inc. →